SERUR: COVID-19 Serological Survey of Staff From the University Reims-Champagne Ardennes

Covid19 Clinical Trial

— SERUR  

Official title:

SERUR : Etude sérologique COVID-19 (Anti-SARS CoV 2) du Personnel de l'Université de Reims Champagne-Ardenne

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04816084
• Other study ID #: 2020-004-SERUR
• Status: Completed
• Phase: N/A
• Start date: November 5, 2020
• Est. completion date: March 15, 2021

Study information

• Verified date: March 2021
• Source: Université de Reims Champagne-Ardenne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was designed to determine, in a screening situation within the framework of university preventive medicine, the prevalence of positive anti-SARS-Cov 2 serology among the staff of the University of Reims Champagne-Ardenne. The serological tests chosen will allow systematic detection of anti-SARS-CoV-2 IgM and anti-SARS-Cov-2 IgG to assess the moment of potential contamination prior to resumption of occupational activity.

Description:

Objective:

This study was designed to determine, in a screening situation within the framework of university preventive medicine, the prevalence of positive anti-SARS-Cov 2 serology among the staff of the University of Reims Champagne-Ardenne. The serological tests chosen will allow systematic detection of anti-SARS-CoV-2 IgM and anti-SARS-Cov-2 IgG to assess the moment of potential contamination prior to resumption of occupational activity.

Type of study:

This is a prevalence study, a single-center cross-sectional study published on the human person.

Population:

Inclusion criteria: On a voluntary basis, the staff of the University of Reims Champagne Ardenne will be offered a serological blood test (1 dry tube of 7ml). The use of the collected data for research purposes will be explained to each requester, with signature of an informed consent. Only people over 18 will be included.

Non-inclusion criteria: Staff of the University of Reims Champagne Ardenne who have not requested to be tested. Duration of participation of subjects: 1/2 day time

Judgment criterion (s):

Main endpoint (in connection with the main objective): Prevalence of positive SARS-CoV-2 serology at the University of Reims Champagne-Ardenne.

Clinical investigation plan:

• Phase 1: Communication strategy An email will be sent to all the staff of the University of Reims Champagne Ardenne to offer them anti-SARS-Cov-2 serological tests, as part of a health research protocol. Before sampling, a questionnaire will be completed by the applicant.

• Phase 2: Analysis of the samples

• Phase 3: Transmission of results to Pr Frédéric Deschamps, head of SUMMPS at the University of Reims Champagne Ardenne

Recruitment information / eligibility

• Status: Completed
• Enrollment: 389
• Est. completion date: March 15, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Major volunteers from the Staff of the University of Reims Champagne-Ardenne (>18 years old)

Exclusion Criteria (Non Inclusion):

• persons who do not desire to participate

Related Conditions & MeSH terms

• Covid19

Intervention

Diagnostic Test:
• Anti-SARS-CoV2 Serology
Diagnostic Test: Anti-SARS-CoV2 Serology A blood sample is collected by venipuncture at Day 0. The anti-SARS-CoV2 serological status is measured by with fully automated MAGLUMI 2019-nCoV IgG and IgM chemiluminescence immunoassays (EUROBIO®) Other: Questionnaire Data concerning personal exposure factors are collected in a questionnaire: Socio-demographic factors: sex, age, known risk-factor for Covid-19 Professional factors: Employment (type, work time, location), protective measures put in place to reduce the risk of contamination Non-professional factors: Contact with infected individuals, carrying of protective equipment and compliance with barrier measures, transport and accomodation modalities during holidays

Locations

Country	Name	City	State
France	Université de Reims Champagne-Ardenne	Reims

Sponsors (1)

Lead Sponsor	Collaborator
Université de Reims Champagne-Ardenne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of IgG and IgM anti-SARS CoV2 antibodies	Anti-SARS-Cov2 seroprevalence measured in blood sample collected at Day 0.	Inclusion time was ½ day, time for blood sampling